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# FDA Clears First 1-Minute HIV Self Test
- URL: https://www.fdaweb.com/fda-clears-first-1-minute-hiv-self-test/
- Published: 2025-10-15T12:00:00.000Z
- Updated: 2026-09-14T15:24:08.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160050

FDA has approved a bioLytical Laboratories PMA for the INSTI HIV Self Test, described by the company as the first at-home HIV test in the U.S. that delivers results in 60 seconds or less. The single-use, rapid, in vitro diagnostic qualitative immunoassay is intended for use in detecting antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) and Type 2 (HIV-2) in human fingerstick whole blood, according to the [FDA approval letter](https://www.fda.gov/media/189218/download?attachment&ref=fdaweb.com). The over-the-counter test is intended for use as a self test by users 18 years or older, and it is not intended to be used with specimens other than fingerstick whole blood, the agency says.